US spends most on this drug… and no one knows how it works

Americans spent over $7.5 billion on one drug over a one-year period ‒ more than any other medication. And yet no one knows how the powerful pill works. But that doesn’t keep Big Pharma from marketing it for a multitude of disorders.

“Quick: what’s the top-selling drug in the United
States?” the Daily Beast asked. “Prozac? Viagra? Maybe
something for heart disease?”

The answer is actually Abilify (aripiprazole), a powerful
antipsychotic used to treat schizophrenia and bipolar disorder, among other major
psychiatric conditions.

Americans spent over $7.5 billion on the drug between October
2013 and September 2014, with nearly 8.8 million prescriptions
filled per month in that same time period, Medscape Medical News
reported. The sales of aripiprazole were more than all other
major antidepressants combined.

Bristol-Meyers Squibb (BMS) initially developed Abilify to treat
schizophrenia ‒ a disease affecting only one percent of
Americans. A few years later, it was approved for bipolar
disorder, an illness that an additional 1.5 percent of Americans
battle. But then the Food and Drug Administration (FDA), which
approves and regulates all medications in the US, allowed the
drug to be used in conjunction with other medications to treat
major depressive disorder, MedShadow Foundation’s Suzanne B.
Robotti reported.

Depression affects 16 million people in the US, Dr. Candida Fink,
an expert in bipolar disease, pointed out to Robotti, adding that
it is a significant and lethal disease.

Once the drug was able to be marketed as an add-on for
depression, its sales soared. (BMS spends $121 million on
promoting Abilify each year, according to MedShadow.) Its
advertisements tout that the drug works “like a thermostat to
restore balance,” and that “[when] activity of key brain
chemicals is too high, Abilify lowers it…. When activity of key
brain chemicals is too low, Abilify raises it.”

The Daily Beast likened the drug to “a bazooka to
conventional anti-depressants’ revolver.”

That’s about as close as anyone gets to explaining how the
powerful, atypical antipsychotic works.

“Our promotional activities focus on the description of the
mechanism of action of aripiprazole as it is written” in the
standardized United States Product Insert (USPI), a spokesperson
for Otsuka, which produces Abilify with Bristol-Meyers Squibb,
told the Daily Beast.

But the USPI doesn’t shed any light on how the drug works. In
fact, it says that the “mechanism of action of aripiprazole…
is unknown.” It suggests a “proposed” way of
working, but does not list any evidence supporting the theory.
The FDA also says the way Abilify works is “unknown.”

A page called "How Abilify is thought to work" on the
the drug's website notes, "Keep in mind that the exact way
ABILIFY works has not been fully determined."

An article in PLoS Medicine, a peer-reviewed journal, called the
advertisements “questionable,” asking “whether the
complexities of treating bipolar disorder (with its unknown
etiology and well-known heterogeneity in response to treatment)
are accurately portrayed as a reliable, mechanical
thermostat.”

“However,” the authors noted, “consumers are likely
to find such advertisements compelling.” The lack of
government regulation or outcry from professional associations
about Otsuka’s claims, they hypothesized, “significantly
contributes to the process of disease mongering.”

“The advertising is everywhere,” Fink told Robotti.
“The effects of the advertising are very vivid to me, I see
it all the time. I talk to my patients about making the best
decision for them and not rely on advertising. But that’s
certainly a big part of why Abilify is selling as much as it is ‒
because of the advertising.”

And patients who rely on television ads are the targets of what
the PLoS authors describe as disease mongering, which is another
way for pharmaceutical companies to grow sales.

“Consumers who view such advertisements are likely to
characterize their problems in a manner congruent with industry
promotion and to request well-advertised pharmaceuticals as
treatment,” they wrote. “At a bare minimum, increased
medicalization will result; in some cases, disease mongering may
indeed be an appropriate characterization.”

Abilify is also used to treat irritability and symptoms of
aggression, mood swings, temper tantrums and self-injury related
to autistic disorder in children who are at least 6 years old,
Drugs.com noted.

Although aripiprazole is the top grossing medication in the US,
it is only the 13th most prescribed. Crestor, a
cholesterol-lowering drug, edged out Synthroid, a hypothyroid
medication, for the top spot, with almost 22.28 million a month
between October and September, compared to 22.56 million per
month. But Crestor’s sales were almost $5.8 billion over that one
year period, while Synthroid’s totalled less than $1 billion,
according to Medscape.